Tag Archives: Dietary Supplements

In the February 2015 Mid-Monthly Advocate issue, I wrote about the New York State Attorney General’s Office crackdown on four major chains (GNC, Target, Walmart, and Walgreens). The stores were selling herbal supplements that contained very little of the stated ingredients listed on the labels and that included contaminants. The testing occurred in the brand named stores throughout New York State.

Good news—GNC Holding announced that it had restocked some of the herbal supplements to their stores in New York after they reached an agreement with the New York Attorney General and complied and corrected the problems. Furthermore, GNC agreed that they would adopt testing standards in the 6,000 stores nationwide that would exceed requirements that the Food and Drug Administration requires—this is a first for a major herbal supplement chain in the United States. Additionally, GNC committed to the following best practices:

Broad Testing for Contaminants: GNC will test for the eight most common allergens before and after production.

Consumer transparency: GNC will prominently display signs in their stores and on their website with relevant information about the herbs and supplements including extracts, chemicals, and solvents used and explain the different processes. GNC will list all ingredients on its product labels, per existing FDA rules.

In related news, 13 state attorneys have asked the U.S. Congress to investigate the herbal supplement industry based on the NY General’s Office investigation. The state attorneys are considering giving the Food and Drug Administration (FDA) more oversight over herbal supplements. However, it has been previously reported that the FDA is considerably underfunded already. The question of undertaking a massive job of regulating herbal supplements would need a large funding package attached to any herbal regulation bill.

Comment: Regarding GNC—this is excellent progress. However, where are the agreements with Target, Walmart, and Walgreens? Hopefully, the other stores will soon agree to the same terms as GNC. If you want to know the potential harm of these herbs, check out the original article—it will make you think twice before buying any herbs or supplements unless there is some type of comprehensive oversight.

In the February 2015 Mid-Monthly Advocate
issue, I wrote about the New York State Attorney General’s Office
crackdown on four major chains (GNC, Target, Walmart, and Walgreens).
The stores were selling herbal supplements that contained very little
of the stated ingredients listed on the labels and that included
contaminants. The testing occurred in the brand named stores
throughout New York State.

Good news—GNC
Holding announced that it had restocked some of the herbal supplements
to their stores in New York after they reached an agreement with the
New York Attorney General and complied and corrected the problems.
Furthermore, GNC agreed that they would adopt testing standards in the
6,000 stores nationwide that would exceed requirements that the Food
and Drug Administration requires—this is a first for a major herbal
supplement chain in the United States.
Additionally, GNC committed to the following best practices:

Broad Testing for Contaminants: GNC will test for the eight most common allergens before and after production.

Consumer transparency: GNC
will prominently display signs in their stores and on their website
with relevant information about the herbs and supplements including
extracts, chemicals, and solvents used and explain the different
processes. GNC will list all ingredients on its product labels, per
existing FDA rules.

In related news, 13 state attorneys have
asked the U.S. Congress to investigate the herbal supplement industry
based on the NY General’s Office investigation. The state attorneys are
considering giving the Food and Drug Administration (FDA) more
oversight over herbal supplements. However, it has been previously
reported that the FDA is considerably underfunded already. The
question of undertaking a massive job of regulating herbal supplements
would need a large funding package attached to any herbal regulation
bill.

Comment:
Regarding GNC—this is excellent progress. However, where are the
agreements with Target, Walmart, and Walgreens? Hopefully, the other
stores will soon agree to the same terms as GNC. If you want to know
the potential harm of these herbs, check out the original article—it will make you think twice before buying any herbs or supplements unless there is some type of comprehensive oversight.

The New York State attorney general’s office accused four major retailers on Monday of selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves.

The authorities said they had conducted tests on top-selling store brands of herbal supplements at four national retailers — GNC, Target, Walgreens and Walmart — and found that four out of five of the products did not contain any of the herbs on their labels. The tests showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies.

The investigation came as a welcome surprise to health experts who have long complained about the quality and safety of dietary supplements, which are exempt from the strict regulatory oversight applied to prescription drugs.

The New York State
attorney general’s office accused four major retailers on Monday of
selling fraudulent and potentially dangerous herbal supplements and
demanded that they remove the products from their shelves.

The authorities said
they had conducted tests on top-selling store brands of herbal
supplements at four national retailers — GNC, Target, Walgreens and
Walmart — and found that four out of five of the products did not
contain any of the herbs on their labels. The tests showed that pills
labeled medicinal herbs often contained little more than cheap fillers
like powdered rice, asparagus and houseplants, and in some cases
substances that could be dangerous to those with allergies.

The investigation came
as a welcome surprise to health experts who have long complained about
the quality and safety of dietary supplements, which are exempt from the
strict regulatory oversight applied to prescription drugs.

As the head of the office that oversees dietary supplements, it is my
responsibility to ensure that the dietary supplement products on the
market — which are used by more than 180 million Americans daily — do
not cause harm.

This
is not an easy job because FDA’s authority to regulate dietary
supplements is very different from the agency’s authority to regulate
drugs and medical devices prior to their marketing. Adding to the
challenge is the fact that there are more than 85,000 dietary supplement
products and no requirement for product registration.

Just recently we had a case that illustrates both the limits of FDA’s
authority to regulate supplements and the promise of new enforcement
tools provided by the FDA Food Safety Modernization Act (FSMA). Dozens
of people were suffering acute liver failure or non-viral hepatitis so
severe that several needed liver transplants, and one died. These
people, by and large, had been healthy.

The illnesses were linked to certain OxyElite Pro dietary supplement
products made by Texas-based USPLabs. Certain OxyElite Pro products and a
second product, VERSA-1, contain a new dietary ingredient that has not
been shown to be safe for use by consumers. This ingredient, aegeline,
is a synthetic version of an alkaloid that exists, in natural form, in a
tree that grows in parts of Asia.

This is the second time in little more than a year that USPLabs has
produced supplements containing a new dietary ingredient that lack a
history of use or other evidence of safety. In the previous case, the
company added a stimulant called DMAA (dimethylamylamine) to OxyElite
Pro and to a similar product, Jack3D. We were alerted to the addition of
DMAA through more than 100 reports of illness, including six deaths,
among people who used the products.

Consumers may look at a capsule or tablet, the forms in which many
supplements are sold, and not realize our limitations in regulating
dietary supplements. In October 1994, the Dietary Supplement Health and
Education Act expressly made supplement manufacturers responsible for
ensuring that their products are safe. Under this law, manufacturers do
not need FDA approval before selling dietary supplements. The burden is
generally on FDA to prove that a supplement is unsafe before any actions
can be taken to restrict its use or remove it from the market.

The law made an exception for “new dietary ingredients” (i.e.,
dietary ingredients not marketed in the United States before Oct. 15,
1994). Before supplements containing these new dietary ingredients –
vitamins, minerals, herbs and other substances – can be sold, a
manufacturer or distributor must provide FDA with information
establishing their safety when used under the conditions recommended or
suggested in the product labeling. USPLabs should have informed FDA of
its plans to add aegeline to its dietary supplements, and it should have
established the safety of aegeline in its products. Neither of those
things happened.

We do not have the authority to evaluate and approve dietary
supplements before they are sold to consumers. However, in this case we
were able to invoke new enforcement authorities provided by FSMA to
remove them from the market.

Key provisions under the new food safety law – mandatory recall and
administrative detention – now play a critical role in allowing FDA to
act quickly and decisively. We can now order a recall when there is a
reasonable probability that an article of food is adulterated or
misbranded under certain sections of the Federal Food, Drug, and
Cosmetic Act and there is also a reasonable probability that the
articles of food will cause serious adverse health consequences or death
to people or animals.
We also have the authority to administratively detain a food or
dietary supplement to prevent its distribution if the agency has reason
to believe the product is adulterated or misbranded.

We invoked our recall authority and warned USPlabs that FDA might
order it to stop distributing the involved OxyElite Pro dietary
supplements if the company did not stop distribution on its own and
conduct a voluntary recall. USPLabs agreed to voluntarily recall the
OxyElite Pro products and destroy all lots of the products, including
remaining warehouse stock, which had an estimated value of $22 million.
We will supervise the destruction of these products.

My colleagues and I will continue to use our new authorities, as
appropriate, to make sure that the supplements you take will not put you
in the hospital. We are committed to keeping you and your family safe,
using every tool at our disposal.

The
state’s Department of Health is investigating at least 10 medical cases
in Hawaii during a four-month period that started in May in which
individuals suffered acute liver inflammation and failure.

The only
common finding among all the Hepatitis cases, at this point, is the use
of a dietary or nutritional supplement for the purpose of weight loss
and/or muscle gain in the past six months. Cases have been reported from
every county in the state. So far, the cases involve patients with no
tie to infectious causes, no history of engaging in high-risk social
activities, and no identified commonly expected risk factors for liver
failure.

Dietary supplements are often part of people’s health regimen. Being healthy includes making
wise choices. This means knowing what goes into your body. If you take an herb or herbal blend,
do you know what you are taking? This glossary provides information on some popular
supplements.

Herbs are used in folk and mainstream medicine. Historically and in many cultures, herbs have
been and continue to be used as tools for health. Because of this power, herbs and supplements
deserve both respect and caution. Just because they are natural and available doesn’t mean that
the average person knows how to use supplements effectively. When learning about
supplements, it is best to read information with a critical mind, INCLUDING what you read in
this glossary.

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